Dec. 11 Company Quick Takes: Kite, Alkermes, argenx, Reblozyl, Denovo-Sunesis
Kite submits BLA for CD19 CAR T in mantle cell
Kite Pharma Inc. submitted Wednesday a BLA to FDA for KTE-X19 to treat mantle cell lymphoma after reporting Phase II data at the American Society of Hematology meeting showing the anti-CD19 CAR T led to a best objective response rate of 93%. The therapy uses the same construct as Yescarta axicabtagene ciloleucel but is manufactured using the XLP T cell selection and lymphocyte enrichment process. The Gilead Sciences Inc. (NASDAQ:GILD) unit said it will submit an MAA to EMA early next year.
FDA warns Alkermes over Vivitrol ads
FDA disclosed Wednesday that it issued a warning letter last week to Alkermes plc (NASDAQ:ALKS)related to an ad for opioid antagonist Vivitrol naltrexone. The agency said the ad lacked a warning for the vulnerability to opioid overdose and reduced opioid tolerance and requested comprehensive plan of action from the company “to disseminate truthful, non-misleading, and complete corrective messages.” An Alkermes spokesperson told BioCentury that the ad in question is not in use, and that the company is finalizing its response to FDA...